Comprehensive pharmacologic therapy for treatment of obesity including cysteine

ABSTRACT

The comprehensive pharmacologic therapy for treatment of obesity including Cysteine is a procedure which involves the administration of a desired therapeutic range of Diethylpropion and/or Phentermine in combination with a SSRI medication and nutritional supplementation for brief and long durations which may be 12 months or more. The preferred procedure involves the administration of drugs in combination which are identified as: Citalopram (Celexa) and Phentermine; Citalopram (Celexa) and Diethylpropion; Citalopram (Celexa), Phentermine, and Diethylpropion. In addition nutritional supplementation such as a multivitamin, 5-Hydroxytryptophan, Cysteine, vitamin B6, vitamin C, Tyrosine, Calcium, and Lysine may be used to enhance the performance of the weight loss treatment program.

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application is a continuation-in-part application from Ser.No. 09/412,701 filed Oct. 5, 1999, the entire contents of which arehereby incorporated by reference.

BACKGROUND OF THE INVENTION

[0002] Research has identified that long term use of medications fortreatment of obesity in patients has resulted in many problems. The twomost significant problems encountered by patients using medications toassist in weight loss, assuming the absence of irreversible side effectsfrom the medications, are that:

[0003] The medications stop working during therapy where at least 40% to50% of patients quit losing weight (plateau) on an average of 3.3 monthsinto therapy; and 5% to 8% of patients who receive drug therapy forweight problems experience the complication where the medications failto assist in appetite suppression where the patient therefore does notlose significant weight.

[0004] In the past long term treatment, defined as treatment longer than3 months to many years, with medications, has raised safety issuesincluding, medication intolerability by the patient, medication sideeffects and most important ineffectiveness of the drugs or the cessationof benefit of the drugs which in turn causes the patient to fall out ofappetite suppression and terminate weight loss.

[0005] A weight loss procedure using SSRI medication is disclosed inU.S. Pat. No. 5,795,895. The potential for patients to obtain goalweight loss under the process of U.S. Pat. No. 5,795,895 is low, and thefailure of the drugs to provide a desired level of performance is at theheart of the problem.

[0006] In the past obesity or weight management procedures, as noted inU.S. Pat. No. 5,795,895, implement a single dosing schedule of SSRImedication for a patient. A single dosing schedule of SSRI medication isnot optimal for a desired level of weight loss performance. Individualsfrequently fail to lose a desired amount of weight when alternativedoses of medication are unavailable.

[0007] Second, patients receiving treatment for weight loss through theuse of medication frequently experience complications such as acessation of performance of the medication due to a “nutritionaldeficiency”. Frequently it is difficult to predict which patients arelikely to experience unacceptable performance of weight loss medicationdue to “nutritional deficiencies”associated with calorie deficit's.

[0008] It is also problematic to predict the outcome of medicationtreatment upon individuals receiving Norepinephrine medications such asPhentermine and/or Diethylpropion. These medications have uniquechemical properties making the outcome of treatment of patientsuncertain. In addition not all medications function to assist in weightloss. In the past SSRI (selective Serotonin Reuptake Inhibitor)medications which have been used in weight loss include FluoxetineHydrochloride (Prozac), Sertraline (Zoloft), Fluvoxamine Maleate(Luvox), and Trazodone Hydrochloride (Desyrel).

[0009] The treatment programs for obesity as known also teach away fromthe use of alternative dosing procedures to effectuate weight loss.Specifically U.S. Pat. No. 5,795,895 teaches that an SSRI medicationnever needs to be raised to improve the anorexiant effect of weight lossand that the SSRI medication level administered to a patient may beraised to assist in the treatment of coexisting conditions such asdepression.

[0010] It is therefore desirable to have a weight loss treatment programfor a patient which provides for an effective therapeutic range ofavailable medication to enhance desired weight loss. It is alsodesirable to provide a weight loss program which minimizes the percentof individuals who do not initially respond to the medication treatmentregime or who cease to continue to receive the beneficial effects of theweight loss program following the initiation of the medication treatmentdue to nutritional deficiencies. These and other problems are solved bythe disclosed Comprehensive Pharmacologic Therapy For Treatment OfObesity.

[0011] A problem has been known in the past where drugs which work onnorepinephrine stop working after a period of time when used in treatingpatients for weight loss. As stated in Wurtman et. al in U.S. Pat. No.4,885,312.

[0012] Indirect-acting sympathomimetic amines (such as Phentermine)function by releasing stored norepinephrine from sympathetic nerveendings. The major problem with their use is that after a few doses,they often stop functioning, i.e., tachyphylaxis sets in. Tachyphylaxisis known to be associated with partial depletion of the norepinephrinein the nerve endings, leading to the supposition that there arereleasable and non-releasable pools of norepinephrine and that when thedrugs cease functioning, it is because the releasable pools have beenseverely depleted.

[0013] The chemical pathway involved is:

[0014] Dopa, doparnuie, norepinephrine, and epinephrine are known as“catecholamines”. Chemically the enzyme “Tyrosine Hydroxylase” limitsthe rate of formation of catecholamines. Another problem as known is toidentify a way to increase the amounts of Tyrosine Hydroxylase or it'sactivity in a patient receiving treatment for obesity. No procedure isknown which uses a dietary precursor approach to increase amounts ofTyrosine Hydroxylase and it's activity in a patient receiving treatmentfor obesity. No procedure is known to increase catecholamine levels in apatient by providing the precursor needed for the formation of TyrosineHydroxylase.

[0015] Catecholamine formation is regulated by a feed back loopinvolving norepinephrine and Tyrosine Hydroxylase. In this loopnorepinephrine binds to each of the four legs of the TyrosineHydroxylase enzyme and through the mechanism of phosphorylation thenorepinephrine deactivates Tyrosine Hydroxylase into a new chemicalknown as “phosphorylated Tyrosine Hydroxylase”. In the process the bodybegins to synthesis more Tyrosine Hydroxylase.

[0016] A complication in the treatment of patients for weight loss isthat drugs which are given to increase the levels of intersynapticnorepinephrine lead to increased phosphorylation of Tyrosine Hydroxylasewhich, in turn, causes increased synthesis of Tyrosine Hydroxylase anddepletion of critical precursors. The net effect of drugs which causeincreased intersynaptic levels of norepinephrine for a patient is thedepletion of precursors need in the synthesis of Tyrosine Hydroxylaseleading to the “tachyphylaxis”.The provision to a patient of theprecursor Tyrosine with co-factors vitamin C, calcium, and vitamin B6will not prevent or reverse the tachyphylaxis induced by drugs whichcause increased levels of intersynaptic norepinephrine.

BRIEF DESCRIPTION OF THE INVENTION

[0017] The invention embodies the use of Phentermine and/orDiethylpropion with an SSRI medication, Citalopram. The SSRI medicationis used in an “effective therapeutic range” to provide optimal results.The treatment enables individuals to have a much higher expectation ofweight loss to achieve a desired weight than the previous knowntreatments. The method of weight loss enables individuals to lose weightoptimally and safely. With treatment, as individuals lose weight otherdiseases or illnesses caused by or associated with weight problems getmarkedly better or resolve completely. These illnesses and/or diseasesare identified as type II diabetes, hypertension, hypercholesterolemia,orthopedic problems, depression, anxiety, panic attacks, migraineheadaches, PMS, chronic pain states, fibromyalgia, insomnia, sleepapnea, impulsivity, obsessive compulsive disorder, and myoclonus.Duration of treatment may be long term, or for life if needed, to reduceweight and maintain weight loss as desired by an individual.

[0018] The treatment of a patient for weight loss may include the use ofCysteine with precursors Tyrosine, 5-Hydroxytryptophan, vitamin C,vitamin B6, and calcium. Use of the precursors and co-factors ofCysteine generally insures that adequate direct precursors are availableto increase catecholamine levels for a patient prolonging theeffectiveness of medication therapy.

[0019] An advantage of the present invention is the provision of acomprehensive pharmacologic therapy for treatment of obesity ofrelatively simple and inexpensive design which fulfills the intendedpurpose of appetite suppression to enable weight loss without fear ofinjury to persons.

[0020] Another principal advantage of the present invention is theprovision of a comprehensive pharmacologic therapy for treatment ofobesity which is easy for patients to initiate and continue toeffectuate weight loss.

[0021] Still another principal advantage of the present invention is theprovision of a comprehensive pharmacologic therapy for treatment ofobesity which is effective for all patients attempting to lose weight.

[0022] Still another principal advantage of the present invention is theprovision of a comprehensive pharmacologic therapy for treatment ofobesity which continues to function to enable patient weight lossfollowing the initiation of therapy by an individual.

[0023] Still another principal advantage of the present invention is theprovision of a comprehensive pharmacologic therapy for treatment ofobesity which promotes appetite suppression while simultaneouslymaintaining nutritional balance for an individual.

[0024] Still another principal advantage of the present invention is theprovision of a comprehensive pharmacologic therapy for treatment ofobesity which minimizes risk of undesirable side effects for a patient.

[0025] Still another principal advantage of the present invention is theprovision of a comprehensive pharmacologic therapy for treatment ofobesity which may be used long term defined as a period of timeexceeding three months.

[0026] Still another principal advantage of the present invention is theprovision of a comprehensive pharmacologic therapy for treatment ofobesity which minimizes risk of medication intolerability for a patient.

[0027] Still another principal advantage of the present invention is theprovision of a comprehensive pharmacologic therapy for treatment ofobesity which minimizes medication side effects and/or complications fora patient.

[0028] Still another principal advantage of the present invention is theprovision of a comprehensive pharmacologic therapy for treatment ofobesity which assists in empowering a patient to achieve a desired goalweight through monitored, healthy, and controlled weight loss.

[0029] Still another principal advantage of the present invention is theprovision of a comprehensive pharmacologic therapy for treatment ofobesity which is flexible to a patient's needs through the provision ofan effective therapeutic range of weight loss medication.

[0030] Still another principal advantage of the present invention is theprovision of a comprehensive pharmacologic therapy for treatment ofobesity which minimizes risk of nutritional deficiency for a patient.

[0031] Still another principal advantage of the present invention is theprovision of a comprehensive pharmacologic therapy for treatment ofobesity which simultaneously treats other diseases or obesity relatedillnesses such as type II diabetes, hypertension, hypercholesterolemia,orthopedic problems, depression, anxiety, panic attacks, migraineheadaches, PMS, chronic pain states, fibromyalgia, insomnia, sleepapnea, impulsivity, obsessive compulsive disorder, and/or myoclonus.

[0032] Still another advantage of the present invention is the provisionof a comprehensive pharmacologic therapy for treatment of obesity whichincludes the regulated prescription of an SSRI medication namely,Citalopram in an effective therapeutic range for a patient to effectuateweight loss.

[0033] Still another advantage of the present invention is the provisionof a comprehensive pharmacologic therapy for treatment of obesity whichincludes the regulated prescription of Phentermine in an effectivetherapeutic range for a patient to effectuate weight loss.

[0034] Still another advantage of the present invention is the provisionof a comprehensive pharmacologic therapy for treatment of obesity whichincludes the regulated prescription of Diethylpropion in an effectivetherapeutic range for a patient to effectuate weight loss.

[0035] Still another advantage of the present invention is the provisionof a comprehensive pharmacologic therapy for treatment of obesity whichincludes the consumption of 5-Hydroxytryptophan by a patient in aneffective therapeutic range to assist in avoiding nutritionaldeficiencies and effectuating weight loss.

[0036] Still another advantage of the present invention is the provisionof a comprehensive pharmacologic therapy for treatment of obesity whichincludes the consumption of Lysine by a patient in an effectivetherapeutic range to assist in avoiding nutritional deficiencies andeffectuating weight loss.

[0037] Still another advantage of the present invention is the provisionof a comprehensive pharmacologic therapy for treatment of weight losswhich includes the consumption of vitamin B6 by a patient in aneffective therapeutic range to assist in avoiding nutritional deficiencyand effectuating weight loss.

[0038] Still another advantage of the present invention is the provisionof a comprehensive pharmacologic therapy for treatment of obesity whichincludes the consumption of vitamin C by a patient in an effectivetherapeutic range to assist in avoiding nutritional deficiency andeffectuating weight loss.

[0039] Still another advantage of the present invention is the provisionof a comprehensive pharmacologic therapy for treatment of obesity whichincludes the consumption of Tyrosine by a patient in an effectivetherapeutic range to assist in avoiding nutritional deficiency andeffectuating weight loss.

[0040] Still another advantage of the present invention is the provisionof a comprehensive pharmacologic therapy for treatment of obesity whichincludes the consumption of a multi-vitamin by a patient to assist inavoiding nutritional deficiency and effectuating weight loss.

[0041] Still another advantage of the present invention is the provisionof a comprehensive pharmacologic therapy for treatment of obesity whichincludes the consumption of calcium by a patient in an effectivetherapeutic range to assist in avoiding nutritional deficiency andeffectuating weight loss.

[0042] Still another advantage of the present invention is the provisionof a comprehensive pharmacologic therapy for treatment of obesity whichincludes the consumption of Lysine in an effective therapeutic range toassist in avoiding nutritional deficiency and effectuating weight loss.

[0043] Still another advantage of the present invention is the provisionof a comprehensive pharmacologic therapy for treatment of obesity whichinvolves consumption of citalopram by a patient for an initial six (6)day period of time at an initial dosage level where the dosage level maybe subsequently modified after the initial six (6) day period of time tomaximize likelihood of success of weight loss by a patient.

[0044] Still another advantage of the present invention is the provisionof a comprehensive pharmacologic therapy for treatment of obesity whichinvolves the monitoring of a patients weight loss progress throughcalculation of “low weight loss” as defined by a patient weight at aprevious visit added to a patient current weight then divided by two (2)followed by multiplication by 10 and then less the current patientweight, less the patient weight at the previous visit, then multipliedby 3,500 and then divided by the number of days between the previousvisit and the date of the current weight for the provision of a firstsum; calculating a second sum by multiplying a patient goal weight timesten then divided by 0.8928; and comparing the first sum to the secondsum where low weight loss occurs when said first sum is larger than saidsecond sum.

[0045] Still another advantage of the present invention is the provisionof Cysteine to a patient receiving treatment for weight loss to reversethe undesirable effects of tachyphylaxis due to the use of a drug whichincreases intersynaptic norepinephrine levels.

[0046] Still another advantage of the present invention is the provisionof Cysteine to a patient receiving treatment for weight loss to reversethe undesirable effects of non-responsiveness to ongoing drug therapy.

[0047] Still another advantage of the present invention is the provisionof Cysteine to a patient receiving treatment for weight loss to reversethe undesirable effects which may arise where the patient has a historyof exposure to toxins both in and out of the work place.

[0048] Still another advantage of the present invention is the provisionof Cysteine to a patient receiving treatment for weight loss to reversethe undesirable effects of fat stores becoming saturated withfat-soluble toxins which may leach into a patient's system.

[0049] Still another advantage of the present invention is the provisionof Cysteine to a patient receiving treatment for weight loss to reverseundesirable effects which may occur due to leaching of fat-solubletoxins such as skin eruptions and depletion of the catecholamine system,where depletion of the catecholamine system may in turn causetachyphylaxis.

[0050] Still another advantage of the present invention is the provisionof Cysteine to a patient receiving treatment for weight loss whereCysteine is provided upon initiation of treatment in order to prevent anutritional deficiency and to maintain the optimal functioning of all ofthe patients biological systems.

[0051] Still another advantage of the present invention is the provisionof Cysteine to a patient receiving treatment for weight loss whereCysteine is provided to patients who are not responding to treatmentwith catecholamine drugs, to effectuate weight loss, or in any othersetting where the catecholamine system of the patient is not functioningproperly.

[0052] Still another advantage of the present invention is the provisionof Cysteine to a patient receiving treatment for weight loss whereCysteine is provided to prevent and reverse tachyphylaxis caused fromuse of catecholamine drugs.

[0053] Still another advantage of the present invention is the provisionof Cysteine to a patient receiving treatment for weight loss whereCysteine is provided to maintain the proper functioning of theglutathione system for the patient.

[0054] Still another advantage of the present invention is the provisionof Cysteine to a patient receiving treatment for weight loss whereCysteine is provided to keep the catecholamine system of the patientfunctioning properly when the patient has a history of exposure totoxins.

[0055] Still another advantage of the present invention is the provisionof Cysteine to a patient receiving treatment for weight loss whereCysteine is provided to help the catecholamine system to functionproperly in combination with the serotonin system.

[0056] Still another advantage of the present invention is the provisionof Cysteine to a patient receiving treatment for weight loss whereCysteine is provided to insure that the body of the patient continues toproduce optimal levels of Tyrosine Hydroxylase for proper function ofthe catecholamine system.

[0057] Still another advantage of the present invention is the provisionof Cysteine to a patient receiving treatment for weight loss whereCysteine is provided to alleviate undesirable symptoms encountered bypatients, once a drug which causes increased levels of norepinephrine inthe synapse is terminated.

[0058] Still another advantage of the present invention is the provisionof Cysteine to a patient receiving treatment for weight loss whereCysteine is provided to restore appetite suppression in patients inweight loss where the patient has experienced problems using theprecursors and co-factors of Tyrosine and/or 5-Hydroxytryptophan.

BRIEF DESCRIPTION OF THE DRAWINGS

[0059]FIG. 1 is a diagram of a Heme-Thiolate Protein.

DETAILED DESCRIPTION OF INVENTION

[0060] The comprehensive pharmacological therapy for treatment ofobesity involves the combination of medications within “effective dosingranges” and “optimal dosing ranges”. The weight loss therapy in generalinvolves the use of effective dosing ranges of Citalopram andPhentermine; Citalopram and Diethylpropion; Citalopram, Phentermine, andDiethylpropion to effectuate weight loss in a patient.

[0061] The use of Citalopram, Phentermine, and Diethylpropion ineffective dosing ranges as well as optimum dosing ranges in conjunctionwith proper replacement of vitamins to counter nutritional deficiencysuccessfully resolves two problems unique to weight loss managementprograms which use medications. The use of Citalopram, Phentermine, andDiethylpropion in conjunction with nutritional supplements in effectivedosing ranges generally achieves acceptable weight loss performance forall patients thereby eliminating the failure of the weight loss programto be effective for five percent to eight percent of the patients whohave initiated medication therapy. In addition, the use of Citalopram,Phentermine, and Diethylpropion in conjunction with nutritionalsupplements in effective dosing ranges also continues to function toassist patients to lose weight beyond a three month period of timethereby solving the problem where 40 percent to 50 percent of thepatients undergoing medication therapy encounter a complication wherethe medication therapy stops working at a plateau which occursapproximately three months on average into the medical treatment.

[0062] Through the proper use of effective dosing ranges and nutritionalsupplementation, generally all patients successfully lose weight fromthe beginning of therapy and continue to lose weight during medicationtherapy until a desired goal weight is obtained. In addition, thereappears to be no irreversible side effects known during use of themedication combinations of Citalopram, Phentermine and Diethylpropion inconjunction with vitamin supplementation. Proper treatment of weightproblems with the disclosed method is highly effective in resolvingadditional problems caused by or associated with obesity such asdiabetes, hypertension, hypercholesterolemia, orthopedic problems,depression, anxiety, panic attacks, migraine headaches and otherassociated obesity related problems.

[0063] The weight loss therapy utilizing medications within an effectivetherapeutic range and/or optimal dosing range provide superior weightloss results in contrast to weight loss treatment programs implementinga single dose SSRI (Selective Serotonin Reuptake Inhibitor) approach. Inthe past, the single dose SSRI medication approach to weight loss ceasedto provide desired performance for a patient resulting in unacceptableweight loss. The failure of the single dose SSRI therapy to adequatelyprovide a desired level of performance frequently results from thepatient having a nutritional deficiency.

[0064] The failure of the single dose SSRI therapy to provide for anacceptable level of weight loss frequently occurs because Serotonin andNorepinephrine are two neurotransmitters implicated in weight problemsand eating disorders. The chemical pathway for manufacturing Serotoninwithin a body is:

[0065] Tryptophan→Hydroxytryptophan→Serotonin. Vitamin B6 and vitamin Cdirectly and indirectly work as co-factors in this chemical equation.

[0066] The chemical pathway for the manufacture of Norepinephrine withinthe body is Tyrosine→Dopamine→Norepinephrine. Patients who arenutritionally deficient in tryptophan or Tyrosine prior to and/or afterinitiation of medication therapy may develop Serotonin and/orNorepinephrine deficiencies respectively. Specifically, SSRI medicationswork with Serotonin and Norepinephrine, such as Phentermine andDiethylpropion, which do not provide adequate performance where adeficiency in Serotonin or Norepinephrine is present. In order to avoida Serotonin and/or Norepinephrine deficiency a patient under thecomprehensive pharmacological therapy for treatment of obesity includingCysteine receives a generic multiple vitamin, 5-Hydroxytryptophan in arange of 50 mg to 900 mg per day, vitamin B6 in a range of 2 mg to 150mgs per day, vitamin C in a range of 50 mg to 2000 mg per day, andTyrosine in a range of 50 mg to 4000 mgs per day, as well as calcium ina range of 50 mg to 2000 mgs per day to prevent bone demineralizationand Lysine in a range of 50 mg to 2000 mgs per day, which is used toprevent hair loss and other protein metabolism problems while a patientis in a medically induced starvation state of weight management. Inaddition, a patient may also receive 500 mg to 5000 mg of Cysteine eachday and 50 mg to 1000 mg of Selenium each day. The 5 percent to 8percent of the patients who did not receive any benefit from theinitiation of medication therapy under the single dose SSRI treatmentregime experience adequate weight loss under the comprehensivepharmacologic therapy for treatment of obesity when a potentialnutritional deficiency was treated simultaneously to the introduction ofthe effective therapeutic range of SSRI medication, Phentermine orDiethylpropion, in conjunction with the vitamin supplementation. Ingeneral, all patients experience weight loss under the comprehensivepharmacological therapy when effective therapeutic ranges of SSRImedication, Phentermine and/or Diethylpropion, and/or vitaminsupplementation is used.

[0067] Within the comprehensive pharmacologic therapy for treatment ofobesity the use of Phentermine and/or Diethylpropion in generic form,should be taken concurrently with Citalopram (Celexa), to treatexogenous obesity. Medication combinations that may be used are“Phentermine and Citalopram”, “Diethylpropion and Citalopram”, and“Phentermine, Diethylpropion and Citalopram”. As is known in the artCelxa® is available from Forest Laboratories, Inc., of New York, N.Y.,and/or Forest Pharmaceuticals, Inc., of St. Louis, Mo. Citalopram is aracemic mixture of both the enatomers S- and R-Citalopram. TheS-Citalopram enatomer is biologically active while the R-enatomer isinactive. As is known in the art, the S-Citalopram enatomer is the SSRIchemical utilized in treating patients. The active S-enantiomer ofCitalopram may be separated from the inactive R-enantiomer of Citalopramand individually utilized in treating patients for weight loss. Thechemical name for Citalopram iscitalopramhydrobromide;(RS)-1-[3-[dimethylamino]propyl]-ρ-fluorophenyl)-5-phthalancarbonitrile,hydrobromide,having the chemical formula c₂₀h₂₂b_(r)FN₂₀.

[0068] During the first week the patient is instructed to take 15 mg ofgeneric Phentermine by mouth each morning along with 10 mg of Citalopramfor the first 6 days followed by 20 mg of Citalopram thereafter todecrease the gastrointestinal side effects of the Citalopram.Diethylpropion may be used with or without Phentermine in combinationwith Citalopram in a daily dosing of 75 mg, short or long acting, ifincreased appetite suppression is desired. A few patients experiencetolerability issues with Diethylpropion and a starting dose of 25 mg perday increased incrementally as tolerated to 75 mg per day may be used.The Phentermine should be given in the morning to minimize sleepdisturbance, experienced on start-up. The SSRI medications may be givenany time during the day with preferential time being at noon. Inaddition to Citalopram other SSRI medications may include FluoxetineHydrochloride (Prosac), Sertralin (Coloft), Fluvoxamine Maleate (Luvox),and Trazodone Hydrochloride (Desyrel).

[0069] On start-up, to minimize the possibility of medicationineffectiveness the patient should consume 50 to 200 mg of5-Hydroxytryptophan a day, Vitamin B6 in the dosing range of 2 to 150 mgper day, Vitamin C in the dosing range of 50 to 2000 mg per day andoptionally Tyrosine in the dosing range of 50 to 4000 mg per day as wellas Calcium in the dosing range of 50-2000 mg per day and Lysine in thedosing range of 50 to 2000 mg per day.

[0070] After the first week of treatment the patients should beevaluated for continued appetite suppression. Appetite suppression maybe identified through patient questioning to ascertain “significanthunger”, snacking, nibbling, failure to adhere to diet, or usingwillpower which induces stress to follow the diet. If appetitesuppression does not appear to have been obtained, then the medicationsand/or nutritional supplements may be further adjusted as needed.

[0071] At a second visit at the end of the first week of treatment, thepatient should have the Phentermine increased from 15 mg taken in themorning to 15 mg taken in the morning and 15 mg taken at noon unlesstolerability issues exist, and the Citalopram dosage should now be at a20 mg daily taken at noon or 10 mg taken at noon and 10 mg taken in thelate afternoon (approximately one hour before the last meal of the day).

[0072] Citalopram may be increased in 20 mg increments in the “effectivetherapeutic range” of 20 mg to 80 mg per day. Phentermine is started at15 mg per day the first week followed by a total daily dosing of 30 mgper day recommended as divided into doses of 15 mg in the morning and 15mg at noon if no problems with tolerance are noted for the patient. Onsubsequent visits, Phentermine may be increased to a total daily dosingof 60 mg per day preferably as divided into doses of 30 mg in themorning and 30 mg at noon. The Phentermine has an “effective therapeuticrange” of 15 mg to 60 mg per day. The daily “optimal dosing range” formost patients consuming Citalopram is 20 mg to 40 mg per day. The daily“optimal dosage range” for most patients with Phentermine is 30 mg to 60mg per day.

[0073] Citalopram may be provided in a dosing range of 10 mg per day forthe first six days of therapy, to minimize start-up side effects,followed by 20 mg per day thereafter. At subsequent visits, if a patientis experiencing low weight loss or significant hunger, Citalopram may beincreased in 20 mg increments in the “effective therapeutic range” of 20mg to 80 mg per day. The Phentermine may have an “effective therapeuticrange” of 15 mg to 60 mg per day. Diethylpropion dosage in the amount of75 mg per day is given. The problems with tolerance developDiethylpropion dosage may be started at 25 mg per day and increased in25 mg per week increments to a total daily dosing of 75 mg if “lowweight loss” or “significant hunger” is present. The “effectivetherapeutic range” of Diethylpropion is 25 mg to 75 mg per day. Thedaily “optimal dosing range” for most patients with Citalopram is 20 mgto 40 mg per day. The “optimal therapeutic range” for most patients forPhentermine is 30 mg to 60 mg per day. The “optimal therapeutic range”for most patients with Diethylpropion is 75 mg per day.

[0074] At initiation of therapy the nutritional supplement dosingschedule may be to provide 50 mg to 200 mg of 5-Hydroxytryptophan, 50 mgto 100 mg of vitamin B6, 50 mg to 1000 mg of vitamin C, 500 mg to 1000mg of Tyrosine, 500 mg to 1000 mg of Lysine, 500 mg to 1000 mg ofcalcium, 500 mg to 5000 mg of Cysteine and 50 mg to 1000 mg of Selenium.If after the first two visits the patient is experiencing “low weightloss” or “significant hunger” the 5-Hydroxytryptophan may be increasedin 100 mg to 300 mg per week increments to a maximum dose of 900 mg perday. If the patient is still refractory to treatment at that point, theTyrosine may be increased in 500 mg to 1000 mg increments to a maximumdose of 4000 mg per day. Once a patient no longer has “significanthunger” or “low weight loss” the 5-Hydroxytryptophan and Tyrosine may beincrementally decreased back to starting doses or to the lowest doseneeded to insure that the patient does not again resume “significanthunger” or “low weight loss”.

[0075] Patients should further schedule follow up appointments no morethan every 2 weeks. At any patient visit should the patient beexperiencing “low weight loss” or “significant hunger”, the patientshould schedule a follow up visit in 1 week.

[0076] “Low weight loss” is defined as:

[0077] 1. Formula 1=[(((weight at previous visit+currentweight)/2)×10)−((weight loss since last visit×3,500)/number of dayssince last visit)]

[0078] 2. Formula 2=[((goal weight*10)×0.8929)]

[0079] 3. When the answer to Formula 1 is greater than the answer toFormula 2 the patient has “low weight loss”.

[0080] After the second visit if the patient still is experiencing“significant hunger”, then the Citalopram should be increased to 40 mg.At subsequent visits if “significant hunger” is still present Citaloprammay be increased incrementally to 80 mg per day total dosing. ThePhentermine may also be increased incrementally to 60 mg per day totaldosing (generally given as 30 mg in the morning and 30 mg at noon). TheDiethylpropion may be increased incrementally to 75 mg per day totaldosing if regular release is utilized.

[0081] During subsequent visits while the medications are beingincreased, the nutritional supplements should also be adjusted. Thepatient should be consuming the basic doses of Vitamin B6, Vitamin C, aswell as Tyrosine, Calcium, a multi-vitamin and Lysine. The5-Hydroxytryptophan should be increased incrementally in 50 to 300 mgdoses from 50, 100, 200, or 300 mg starting doses in 100 mg to 300 mgincrements to a maximum dosing of 900 mg per day following each visit asthe patient continues to express hunger. Once the patients are inadequate appetite suppression for 7-10 days, the 5-Hydroxytryptophan maybe decreased to the first initial dose below which the patientexperienced appetite suppression that being 300 or 100 mg per day. The300 mg dose should be maintained at that level for 2-3 weeks prior totrying to decrease the dosage further to 100 mg per day of5-Hydroxytryptophan. If at any time the patient does begin to experiencehunger after lowering 5-Hydroxytryptophan doses, then the daily doseshould be increased back to the dosage that induced full appetitesuppression. It should be noted that for patients who have previouslyconsumed 5-Hydroxytryptophan for appetite suppression successfully, andwho have terminated the consumption of 5-Hydroxytryptophan andexperienced hunger, then the patient will likely be required to restartthe consumption of 5-Hydroxytryptophan from the initial dose andduplicate the amount of time necessary to return to full appetitesuppression. For example, a patient who initially received 20 days ofadditional 5-Hydroxytryptophan to obtain appetite suppression and wherethe patient was no longer taking the additional 5-Hydroxytryptophanfollowing a loss of appetite suppression which resulted in the return ofhunger then, the patient will likely be required to receive 20additional days of 5-Hydroxytryptophan to once again return to fullappetite suppression. All patients consuming 5-Hydroxytryptophan shouldbe encouraged to increase the dosage of 5-Hydroxytryptophan if hunger isexperienced upon the lowering of the dosage.

[0082] Once a patient has obtained adequate appetite suppression throughincreased dosage of Citalopram within the “effective therapeutic range”of 10 mg to 80 mg per day, and with regulation of nutritionalsupplements, an attempt should be made within 1 to 3 months afterappetite suppression is induced to lower the patient's Norepinephrineand SSRI medication dosage. Many patients at the point in time are ableto be maintained on lower dosages of SSRI medication through nutritionalsupplementation which enhance the underlying Serotonin andNorepinephrine levels.

[0083] As the patients are treated with weight management, calorieprescriptions may be needed to ensure that the patient is fullycognizant of their food intake while in appetite suppression. Calorieprescriptions are not only important from the aspect that the patientswill lose optimal weight by eating at their calorie prescription, but itis also important to make sure the patients are consuming enough foodand not entering into a starvation state with subsequent ketosis whichis cardiotoxic. A calorie prescription developed may be:

[0084] 1. CALRX=((goal weight(which in most cases we use the high endweight on the Metropolitan Tables)×10)−500).

[0085] Patients should use ketostix at least once daily to ensure thatthey are not going into a true starvation state and experiencingketosis. Exposure to a deep state of ketosis for a long period of timemay be fatal from cardiac dysrhythmia.

[0086] An initial medical work-up for patients may include a thyroidpanel. Approximately 12.5% of patients having obesity problems also havenever been properly diagnosed for a hypothyroid abnormality. It may alsobe beneficial to perform a chem-screen panel to ensure that electrolytebalance and organ function is intact prior to inducing patients into amedical starvation state of weight loss. A cell blood count, a urineanalysis, as well as an EKG may also assist to insure that there are nounderlying heart problems which may be exacerbated by very low caloriediet.

[0087] With regards to exercise, patients are instructed that, “exerciseis not to lose weight, it is to tone the body”. Patients are alreadylosing optimal weight through the calorie prescription. If patientsdesire to receive a high intensity work-out the patients will berequired to eat more food to ensure that they do not go into ketosisfrom lowering their effective caloric intake by burning extra calories.

[0088] With regards to treatment of type II Diabetes, most diabetics mayterminate insulin consumption safely with initiation of therapy.Patients should be switched over to maximum dose double oralhypoglycemic therapy and evaluate their blood sugars four times a day.Further the patients may be placed on a sliding scale with regularinsulin where the patient may respond to each individual blood sugarreading with appropriate levels of Regular insulin should their bloodsugars be elevated. Most type II diabetics will need no further shots ofinsulin after initiation of therapy. There is a need for moderately goodcontrol of Diabetes prior to initiation of therapy. As type II diabeticscontinue to lose weight most reach a point where all diabetesmedications may be withdrawn. Patients with blood sugars that arerelatively high should have them brought under control prior toinitiation of therapy.

[0089] If weight loss is low during therapy and the patient claims thatthey are in good appetite suppression and not experiencing “significanthunger”, the patient's calorie counting should be vigorously evaluatedand proper teaching undertaken with the patient as well asconsiderations made for increasing the patients medication and/ornutritional supplement dosing as previously discussed.

[0090] After a patient reaches goal weight or ideal body weight, thepatient needs to be individually assessed for long term maintenance toprevent weight regain. If the patient has a history of having medicallydieted in the past and gaining significant weight back, these patientsmay simply be maintained on lower doses of medications. If the patientdoes not have a history of medically dieting in the past, then themedications may be removed for four to eight weeks in order to evaluatethe continuing need for medications to maintain weight loss. Themedications for patients placed directly on maintenance and continued onmedications, should be reduced progressively back at 2 week incrementsto the lowest possible level to maintain weight. While on maintenance apatient should continue on nutritional supplementation as describedpreviously. Any of the previously discussed combinations of medicationsare acceptable in maintenance as long as the patient tolerates thecombination and is effective maintaining weight loss.

[0091] As far as standards for implementing care in patients the “BodyMass Index” (BMI) is used. The BMI is defined as the body weight inkilograms divided by the square of the height in meters. If the patientshave BMI of 30 or above they are a candidate for weight therapy and ifthe BMI is 25 or above with significant co-morbidity such as Diabetes,Hypertension, Hypercholesterolemia, they patient can be treated at a BMIof 25 or greater.

[0092] There are numerous medical counter indications to weight therapyincluding severe tremor, uncompensated for Schizophrenia, Activetachycardia, Severe narrowing of Glaucoma, Symptomatic gall stones,obstructive enlarged prostate, history of allergy intolerance toPhentermine or SSRI medication, or Diethylpropion, Diabetes out ofcontrol, severe hypertension, angina pectoris, recurrent myocardialinfarction, congestive heart failure, epilepsy, hyperthyroidism. Inaddition patients taking the medications Beta blockers, Theophylline,Ritalin, oral Beta-agonist should not take weight loss medications inaddition to these other medications. Caffeine in the diet should also bereduced.

[0093] The adjustment of SSRI medications within a dosing range is muchmore effective than utilization of a single dose of medicine to treatall patients. By increasing medications in the dosing range and usingnutritional supplements an effective appetite suppression may be inducedwith all patients, including patients who are new to therapy and thosepatients who have prior experience with the medications.

[0094] The treatment of a patient for weight loss may include the use ofCysteine with precursors Tyrosine, 5-Hydroxytryptophan, vitamin C,vitamin B6, and calcium. Use of the precursors and co-factors ofCysteine generally insures that adequate direct precursors are availableto increase catecholamine levels for a patient prolonging theeffectiveness of medication therapy.

[0095] The core of Tyrosine Hydroxylase is a “heme-thiolate” protein(see FIG. 1). The “heme-thiolate” protein is composed of iron in theform of a cytochrome P-450 complex and Cysteine. Patients experiencingtachyphylaxis from drugs which cause increased levels of norepinephrinein the synapse, generally have serum iron levels which are normal.Patients who are experiencing tachyphylaxis from drugs which causeincreased levels of norepinephrine in the synapse respond to Cysteinetherapy, which in turn is effective in reversing the tachyphylaxis.

[0096] Cysteine with or without other precursors in the neurotransmittersystem may resolve tachyphylaxis and in the process increasecatecholamine levels to provide optimal results in patients receivingtreatment for obesity. Cysteine with or without other precursors in theneurotransmitter system may include, but are not necessarily limited toTyrosine and co-factors of Tyrosine which may include but are notnecessarily limited to vitamin C, calcium, and vitamin B6.

[0097] The intersynaptic levels of norepinephrine may increase by asmuch as 2,500 times or more with drugs such as Phentermine which areused in the treatment of a patient for weight loss.

[0098] Depletion of Cysteine may occur not only from the norepinephrineto Tyrosine Hydroxylase feedback loop, but Cysteine may also be depletedby the Cysteine/glutathione system, which is the main oxidation pathwayin the body. The Cysteine/glutathione system in the presences of toxinsmay contribute to depletion of the catecholamine system. The depletionof the catecholamine system by drugs which cause increased levels ofnorepinephrine may further cause dysfunction in the Cysteine/glutathionesystem and it's ability to properly process toxins in the body.

[0099] Cysteine may be used to increase catecholamine production notonly in patients who have been taking drugs which increasenorepinephrine levels in the synapse, but may also be used in treating apatient who has a history of toxin exposure leading to depletion of thecatecholamine system, and further in patients who appear depleted ofcatecholamines without an obvious cause.

[0100] Many patients after termination of treatment involvingintroduction of a drug that increases intersynaptic levels ofcatecholamines such as Phentermine experience numerous long termproblems which may persist for many months or even years. These problemsinclude, but are not necessarily limited to depression, anxiety, panicattacks, trouble concentrating, premenstrual syndrome, insomnia,headaches, etc. The use of Cysteine with precursors and co-factorseffectively control and alleviate these problems.

[0101] The use of 5-Hydroxytryptophan, is generally not a precursor ofthe catecholamine system; but is a precursor of the serotonin system.The serotonin system and the catecholamine system are generally bothrequired to be functioning properly and optimally for a patient, in thatthe dysfunction of one system may significantly affect the other system.Generally, Cysteine may be added to the precursors and co-factors ofTyrosine to alleviate the problems and complications as identifiedherein.

[0102] The precursors of 5-Hydroxytryptophan and Tyrosine in combinationwith vitamin C, vitamin B6, and calcium may be used in vitamin therapyand/or in combination with drug therapy to effectuate weight loss in apatient. Cysteine may be combined with the SSRI medications or vitamin'sas identified above in the amount of 500 mg to 5,000 mg per day. Inaddition, Selenium in the amount of 50 mcg to 1,000 mcg per day may beadded with the Cysteine. Cysteine may have the ability to concentratemercury into the central nervous system, and Selenium is noted for it'sability of bind mercury into a biologically unavailable form. Theintroduction of Cysteine preferably initiates at the inception oftherapy. However, Cysteine may be introduced at any time during thetreatment of a patient for weight loss.

[0103] Patients who are receiving medication which increases the levelsof norepinephrine should also receive Cysteine upon the initiation oftreatment. Medications which cause an increased level of norepinephrineinclude but are not necessarily limited to: Thentennine; Diethylpropion;Phendimetrazine; Effexor; Merdia; Phenylpropanolamine; Welbutrin; andRemeron.

[0104] At the core of the “Tyrosine Hydroxylase enzyme” is aheme-thiolate protein. This protein is made up of an “iron-Cysteine”complex. FIG. 1, is a graphic representation of the heme-thiolateprotein at the core of the Tyrosine Hydroxylase enzyme. In therepresentation the “S” (sulfur group) is from the cysteine group (cyx).The iron group is part to the cytochrome P-450 system.

[0105] The above Examples and disclosure are intended to be illustrativeand not exhaustive. These examples and description will suggest manyvariations and alternatives to one of ordinary skill in this art. Allthese alternatives and variations are intended to be included within thescope of the attached claims. Those familiar with the art may recognizeother equivalents to the specific embodiments described herein whichequivalents are also intended to be encompassed by the claims attachedhereto.

What is claimed is:
 1. A method to facilitate weight loss for a patientnot suffering from depression, said method comprising: A. administrationof a selective Serotonin reuptake inhibitor (SSRI); B. administration ofPhentermine; and C. administration of 5-Hydroxytryptophan, Cysteine,Vitamin B6, and Vitamin C, wherein said SSRI, said Phentermine, said5-Hydroxytryptophan, said Cysteine, said Vitamin B6, and said Vitamin Care administered in an effective therapeutic range to effectuate weightloss.
 2. The method according to claim 1, said effective therapeuticrange comprising: A. the administration of 10 mg of said SSRI each dayfor a period of six days followed by the administration of a dailydosage of between 10 mg and 80 mg of said SSRI; B. the administration of15 mg of said Phentermine each day for said period of six days followedby the administration of a daily dosage of between 15 mg and 60 mg ofsaid Phentermine; and C. the administration of 50 mg to 900 mg of said5-Hydroxytryptophan each day, 2 mg to 150 mg of Vitamin B6 each day, 500mg to 5000 mg of Cysteine each day, and 50 mg to 2000 mg of Vitamin Ceach day until a target weight for said patient is obtained.
 3. Themethod according to claim 2, further comprising the administration of:A. 50 mg to 4000 mg of Tyrosine each day; B. 50 mg to 2000 mg of Calciumeach day; and C. 50 mg to 2000 mg of Lysine each day.
 4. The methodaccording to claim 3, wherein said administration of said SSRI and theadministration of said Phentermine is increased when said patientexperiences low weight loss, said low weight loss comprising: A. saidpatient weight at a previous visit plus said patient current weightfirst divided by 2 and then multiplied by 10, less said current patientweight, less said patient weight at said previous visit, multiplied by3500, divided by the number of days between the date of the previousvisit and the date of said current weight for the provision of a firstsum; B. calculating a second sum by multiplying a patient goal weight by10 and then divided 0.8929; and C. comparing said first sum to saidsecond sum where low weight loss occurs when said first sum is largerthan said second sum.
 5. The method according to claim 3, furthercomprising the administration of 50 mg to 1000 mg of Selenium each day.6. A method to facilitate weight loss for a patient not suffering fromdepression, said method constructed and arranged to increase theconcentration level of neurotransmitters for said patient, said methodcomprising: A. administration of a selective Serotonin reuptakeinhibitor (SSRI); B. administration of Phentermine; and C.administration of 5-Hydroxytryptophan, Vitamin B6, Cysteine, and VitaminC, wherein said SSRI, said Phentermine, said 5-Hydroxytryptophan, saidVitamin B6, said Cysteine, and said Vitamin C are administered in aneffective therapeutic range to effectuate weight loss.
 7. The methodaccording to claim 6, said effective therapeutic range comprising: A.the administration of 10 mg of said SSRI each day for a period of 6 daysfollowed by the administration of a daily dosage of between 10 mg and 80mg of said SSRI; B. the administration of 15 mg of said Phentermine eachday for said period of 6 days followed by the administration of a dailydosage of between 15 mg and 60 mg of said Phentermine; and C. theadministration of 50 mg to 900 mg of said 5-Hydroxytryptophan each day,2 mg to 150 mg of Vitamin B6 each day, 500 mg to 500 mg of Cysteine eachday, and 50 mg to 2000 mg of Vitamin C each day until a target weightfor said patient is obtained.
 8. The method of claim 7, furthercomprising the administration of Tyrosine, a multi-vitamin, Calcium, andLysine.
 9. The method according to claim 8, further comprising theadministration of: A. 50 mg to 4000 mg of Tyrosine each day; B. 50 mg to2000 mg of Calcium each day; and C. 50 mg to 2000 mg of Lysine each day.10. The method according to claim 9, wherein said administration of saidSSRI and the administration of said Phentermine is increased when saidpatient experiences low weight loss, said low weight loss comprising: A.said patient weight at a previous visit plus said patient current weightfirst divided by 2 and then multiplied by 10, less said current patientweight, less said patient weight at said previous visit, multiplied by3500, divided by the number of days between the date of the previousvisit and the date of said current weight for the provision of a firstsum; B. calculating a second sum by multiplying a patient goal weight by10 and then divided 0.8929; and C. comparing said first sum to saidsecond sum where low weight loss occurs when said first sum is largerthan said second sum.
 11. The method according to claim 9, furthercomprising the administration of 50 mg to 1000 mg of Selenium each day.